Research Project
10325512
Project Summary/ Abstract Significance: There is a clear unmet need to reduce the treatment time and cost of the more than 3 million patients with chronic leg wounds draining 3% of annual healthcare expenditure in the US alone. Standard care is to manage wound moisture through dressing changes, swelling through multilayer compression wraps for venous wounds and offloading via removable cast walker for diabetic wounds, and to prescribe daily ambulation and elevation on the part of both types of patient. Wound dressings are changed once or twice a week based on guesswork by specialists at a wound care center or in the home by a visiting nurse for the 3-6 months (or longer) that is required to heal. While standard care has been demonstrated to effectively heal chronic leg wounds, unfortunately in more than 50% of visits, wound dressings are changed too early or too late, leading to lost healing days. Compression wraps lose therapeutic pressure or removable cast walkers are not worn and patients often fail to ambulate more than 10 minutes per day or to elevate their wounded leg while sedentary leading to further delays in healing. Innovation: SuraMedical?s proposed Phase I research seeks to demonstrate the clinical efficacy of our innovative prototype WoundAlert treatment monitoring system in reducing the time to heal chronic leg wounds. WoundAlert enables real-time monitoring and optimization of critical standard care treatment parameters such as dressing moisture and wrap pressure as well as patient engagement and compliance through ambulation and leg elevation tracking. This is accomplished via a wireless wearable sensor tag paired to a mobile app for patient data and engagement and overseen by a clinician cloud dashboard interface. Preliminary Data: Research to date has involved development of prototype hardware and software, lab and human subject performance testing, as well as exploring the commercial opportunity with potential partners and investors. Study of the prototype system with healthy volunteers has led to system improvements to be undertaken in Aim 1 of the proposed work in preparation for clinical study in Aim 2. Specific Aims: Development of a minimum viable clinical prototype is the goal of Aim 1 based on preliminary data and testing. Milestones are a clinical prototype system with 6-month battery life and manufacturable design with <$20 cost at >10k quantity, validated by focus group testing with 10 wound care providers. Aim 2 focuses on demonstrating WoundAlert system clinical efficacy in increasing the rate of healing in venous leg wounds through a clinical study with real time monitoring of a 15 patient intervention arm compared to a 15 patient control arm. The metric for success will be a statistically significant (p<0.05) increase of greater than 10% in wound healing rate. Follow up work in Phase II will close the loop on improvements illuminated by the proposed Phase I work and lead to definitive efficacy studies, FDA submission for clearance and a commercial product with the potential to impact patient outcomes and system-wide healthcare costs.
